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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR MOTOR, RENTAL

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THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR MOTOR, RENTAL Back to Search Results
Model Number L102956
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 08/02/2019
Event Type  Injury  
Manufacturer Narrative
There was no patient involvement in this event. The motor has been received for analysis but the evaluation is not complete. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that during priming of a circuit, the motor overheated. The motor was switched to the backup motor. No alarms were observed during this event.
 
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Brand NameCENTRIMAG MOTOR
Type of DeviceMOTOR, RENTAL
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key8912933
MDR Text Key154961514
Report Number2916596-2019-03891
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberL102956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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